Lower back and leg pain
Conditions
Interventions
Trade Name: Enbrel
Product Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the pla
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A potential participant must be willing and able to give written informed consent prior to admission to the study. Participant must be ASA I-III. Participant must be aged 18-65 Participant must be deemed suitable to be scheduled for an epidural steroid injection for lower back and leg pain of more than one month's duration and up to nine months. Participant must have a chest X-ray prior to admission to the study, within the last six months (to exclude TB and malignancy) Females of childbearing age must have a negative urine pregnancy test on the day of the study and must be using an acceptable method of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A history of diabetes mellitus A history of uncontrolled chronic disease Evidence of immunosupression (including current steroid treatment, immunodeficiency or HIV positive status) A history of TB Pain less than a month or more than nine months duration Previous back surgery Previous chronic pain interventions Presence of any of the following: 1) recent bowel or bladder disturbance, 2) motor deficit, 3) saddle anaesthesia, 4) suspected malignancy (primary or secondary) A history of spinal or neurological disease A history of congestive heart failure Known hypersensitivity to anit-TNF (Enbrel) Any contraindications to anti-TNF (Enbrel) in the Summary of Product Characteristics Pregnancy or lactation Patients who are unwilling or unable to conform to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to establish if there is any acute analgesic effect of anti-TNF (Enbrel) treatment in patients with lower back and leg pain. ;Secondary Objective: To demonstrate the time to onset, duration of effect and magnitude of analgesic response. To demonstrate improvement in dynamic pain measurements. To demonstrate improvement in disability score. To establish if there is a link between pre-intervention blood levels of CRP and the magnitude of response to anti-TNF treatment.;Primary end point(s): Severity of pain as identified by VAS (visual analogue scale). | — |
Countries
United Kingdom
Outcome results
None listed